Cleared Traditional

K760235 - SUTURE GUIDE (FDA 510(k) Clearance)

K760235 · Cutter Laboratories, Inc. · Physical Medicine device
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Jul 1976
Decision
11d
Days
-
Risk

K760235 is an FDA 510(k) clearance for the SUTURE GUIDE.

Submitted by Cutter Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 26, 1976 after a review of 11 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cutter Laboratories, Inc. devices

Submission Details

510(k) Number K760235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1976
Decision Date July 26, 1976
Days to Decision 11 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 115d · This submission: 11d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -